SYSTEMS AND METHODS FOR CLINICAL DECISION MAKING FOR A PATIENT RECEIVING A NEUROMODULATION THERAPY BASED ON DEEP LEARNING
20220379118 · 2022-12-01
Inventors
Cpc classification
G16H20/70
PHYSICS
A61N1/37247
HUMAN NECESSITIES
G16H20/40
PHYSICS
G16H50/20
PHYSICS
G16H50/70
PHYSICS
International classification
Abstract
Information relevant to making clinical decisions for a patient is identified based on electrical activity records of the patient's brain and electrical activity records of other patients' brains. A deep learning algorithm is applied to an electrical activity record of the patient, i.e., an input record, and to a set of electrical activity records of other patients, i.e., a set of search records, to obtain an input feature vector of the patient and a set of search feature vectors, each including features extracted by the deep learning algorithm. A similarities algorithm is applied to the input feature vector and the set of search feature vectors to identify a subset of search records most like the input record. Clinical information associated with one or more search records in the identified subset of search records is extracted from a database and used to make decisions regarding the patient's neuromodulation therapies.
Claims
1. A method of determining stimulation parameter settings that define a stimulation therapy deliverable by a neurostimulation system of a patient, the method comprising: applying a similarities algorithm to at least one input feature vector derived from at least one input record of the patient and a set of search feature vectors, each search feature vector derived from a search record of another patient, to identify a subset of search records having a threshold measure of similarity with the at least one input record; and extracting from a database, clinical information associated with one or more of the search records of other patients in the identified subset of search records of other patients, the clinical information comprising the stimulation parameter settings comprising at least one of amplitude, pulse width, burst duration, and frequency.
2. The method of claim 1, wherein the at least one input feature vector is a single input feature vector, and further comprising: applying a deep learning algorithm to the at least one input record of the patient to extract a plurality of different features from the input record and derive the single input feature vector.
3. The method of claim 1, wherein the at least one input record comprises a plurality of input records and the at least one input feature vector is a single input feature vector, and further comprising: for each of the plurality of input records, applying a deep learning algorithm to the input record to extract a plurality of different features and derive an input feature vector; and applying a similarities algorithm to the input feature vectors to identify one of the input feature vectors as the single input feature vector.
4. The method of claim 1, wherein the at least one input record comprises a plurality of input records and the at least one input feature vector comprises a plurality of input feature vectors, and further comprising: for each of a plurality of input records of the patient, applying a deep learning algorithm to the input record to extract a plurality of different features and derive an input feature vector; grouping the plurality of input feature vectors into sets of input feature vectors based on information included in each of the plurality of input records; and for each set of input feature vectors, applying a similarities algorithm to the input feature vectors in the set to identify one of the input features vectors in the set as one of the plurality of input feature vectors.
5. The method of claim 4, wherein the information associated with the input records indicates whether an input record resulted from one of: 1) detection of an abnormal neurological event, 2) patient initiated recording and storage, 3) periodic automated recording and storage, or 4) periodic recording and storage of baseline, normal neurological activity.
6. The method of claim 4, wherein applying a similarities algorithm comprises, for each of the plurality of input feature vectors: applying the similarities algorithm to the input feature vector and the set of search feature vectors to identify a separate subset of search records having a threshold measure of similarity.
7. The method of claim 1, wherein each search feature vector in the set of search feature vectors comprises a plurality of different features extracted by a deep learning algorithm from a corresponding search record.
8. The method of claim 1, wherein the at least one input record and each search record included in the set of search records are in a same format comprising one of data sample of a time series waveform, a time-series waveform image, and a spectrogram image.
9. The method of claim 1, wherein the clinical information further comprises at least one of associated patient clinical responses, clinical history, past detection parameter settings, past stimulation settings, and past and current drug type and dosage information.
10. The method of claim 1, further comprising: extracting one or more search records included in the identified subset of search records from the database; and providing an output to a user interface, the output comprising information that enables a user device to display the one or more search records.
11. A processor configured to determine stimulation parameter settings that define a stimulation therapy deliverable by a neurostimulation system of a patient, the processor comprising: a similarities module configured to applying a similarities algorithm to at least one input feature vector derived from at least one input record of the patient and a set of search feature vectors, each search feature vector derived from a search record of another patient, to identify a subset of search records having a threshold measure of similarity with the at least one input record; and an extraction module configured to extract from a database, clinical information associated with one or more of the search records of other patients in the identified subset of search records of other patients, the clinical information comprising the stimulation parameter settings comprising at least one of amplitude, pulse width, burst duration, and frequency.
12. The processor of claim 11, wherein the at least one input feature vector is a single input feature vector, and further comprising a feature extraction module configured to: apply a deep learning algorithm to the at least one input record of the patient to extract a plurality of different features from the input record and derive the single input feature vector.
13. The processor of claim 11, wherein the at least one input record comprises a plurality of input records and the at least one input feature vector is a single input feature vector, and further comprising a feature extraction module configured to: for each of the plurality of input records, apply a deep learning algorithm to the input record to extract a plurality of different features and derive an input feature vector; and apply a similarities algorithm to the input feature vectors to identify one of the input feature vectors as the single input feature vector.
14. The processor of claim 11, wherein the at least one input record comprises a plurality of input records and the at least one input feature vector comprises a plurality of input feature vectors, and further comprising a feature extraction module configured to: for each of a plurality of input records of the patient, apply a deep learning algorithm to the input record to extract a plurality of different features and derive an input feature vector; group the plurality of input feature vectors into sets of input feature vectors based on information included in each of the plurality of input records; and for each set of input feature vectors, apply a similarities algorithm to the input feature vectors in the set to identify one of the input features vectors in the set as one of the plurality of input feature vectors.
15. The processor of claim 14, wherein the information associated with the input records indicates whether an input record resulted from one of: 1) detection of an abnormal neurological event, 2) patient initiated recording and storage, 3) periodic automated recording and storage, or 4) periodic recording and storage of baseline, normal neurological activity.
16. The processor of claim 14, wherein the similarities module applies a similarities algorithm by being further configured to, for each of the plurality of input feature vectors: apply the similarities algorithm to the input feature vector and the set of search feature vectors to identify a separate subset of search records having a threshold measure of similarity.
17. The processor of claim 11, wherein each search feature vector in the set of search feature vectors comprises a plurality of different features extracted by a deep learning algorithm from a corresponding search record.
18. The processor of claim 11, wherein the at least one input record and each search record included in the set of search records are in a same format comprising one of data sample of a time series waveform, a time-series waveform image, and a spectrogram image.
19. The processor of claim 11, wherein the clinical information further comprises associated patient clinical responses, clinical history, past detection parameter settings, past stimulation settings, and past and current drug type and dosage information.
20. The processor of claim 11, wherein the extraction module is further configured to: extract one or more search records included in the identified subset of search records from the database; and provide an output to a user interface, the output comprising information that enables a user device to display the one or more search records.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] Various aspects of apparatuses and methods will now be presented in the detailed description by way of example, and not by way of limitation, with reference to the accompanying drawings, wherein:
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DETAILED DESCRIPTION
[0027] Disclosed herein in detail are methods and systems that, for a patient receiving a form of neuromodulation therapy, (1) search for similarities in clinical data corresponding to electrical activity recorded from the subject patient's brain; (2) identify, and in some cases analyze, similar records of electrical activity recorded from other patients' brains; (3) identify clinical information corresponding to the therapy(ies) the other patients are receiving/have received and the outcomes; and (4) use the similar records of electrical activity and the clinical information to inform adjustments to the therapy of the subject patient.
[0028] Hereinafter, “EEG” will be used as shorthand to refer to clinical data corresponding to electrical activity of a patient's brain and “EEG records” will be used to refer to recordings of EEGs maintained in the system. It will be understood that “EEG” includes electrical activity sensed directly from the neural tissue, which sometimes is referred to as electrocorticographic activity, an electrocorticogram, or “ECoG”. The “clinical information” may be referred to herein as “additional information” or simply as “information” and may include any and all information relating to a patient whose EEG records are used in the disclosed methods and systems. The information may include, without limitation, a patient's clinical response to a therapy (e.g., electrical stimulation) or combination of therapies (e.g., electrical stimulation and drug therapy), medical history (for example, as from a patient's electronic health record or other diagnostic information), history of settings for an active implantable medical device (such as the values of the parameters in a neurostimulator), history of a pharmaceutical (drug) therapy (e.g., type of drug(s), dose of drug, time of delivery of dose), the outcomes or other measure of effectiveness of a given course of treatment or therapy for the patient, and the results of an analysis of data pertaining to the patient, such as an algorithm that classifies the patient's EEG records into one or more types. As used herein, a “neuromodulation therapy” is one that is intended to alter neuronal activity through targeted delivery of a stimulus, such as electrical stimulation or a chemical agent such as a drug, at specific neurological sites in a patient's body.
[0029] The identified clinical information may be used, for example, by a clinician to make decisions regarding adjustments or changes to a patient's neuromodulation therapy. Alternatively, the identified clinical information may be used by components of a system to automatically reprogram one or more operational features of the patient's implanted neurostimulation system.
[0030] The search and identification operations of the disclosed methods and systems are based on records of electrical activity of the patient's brain and electrical activity of other patients' brains. In general, the method and system rely on a database of EEG records for patients across a patient population, and EEG records of a subject patient. A typical EEG record may correspond to electrical activity of the brain as sensed and recorded by a neurostimulation system. An EEG record may correspond to a digital representation of a time series waveform or an image, such as a spectrogram, of the electrical activity. While the methods and systems herein are primarily described with reference to records comprising brain electrical activity, it will be appreciated that records could also be used that comprise other data, such as measures of other types of physiological activity (e.g., accelerometer recordings, heart rate, blood oxygenation values, neuromodulator concentrations, etc.).
[0031] In an example operation of the system, one or more input records corresponding to electrical activity of the subject patient are obtained. For example, a clinician may select one or more input EEG records from the database, which may correspond to one or a few EEG records of the subject patient in a spectrogram form. A set of search EEG records stored in a database and corresponding to EEG records of patients other than the subject patient is also obtained. The obtained search EEG records are of the same type as the input EEG records. For example, if the input EEG record is a spectrogram, then the search EEG records are also spectrograms.
[0032] A deep learning algorithm is applied to the input EEG records to obtain an input feature vector that includes a plurality of different features extracted from the input EEG records. The same deep learning algorithm is applied to the set of search EEG records to obtain a corresponding set of search feature vectors, each including a plurality of different features extracted from one of the search EEG records. The deep learning algorithm may be, for example, a convolution neural network, recurrent neural network, or a deep neural network configured to derive features from the input EEG record and the search EEG records. These deep learning algorithms are described in Deep Learning, by Yann LeCun, Yoshua Bengio and Geoffrey Hinton. Nature, published May 27, 2015, Volume 521, pp 436-444. The input feature vector and search feature vector typically each contain thousands of rows, where each row corresponds to a feature extracted from the record by the deep learning algorithm. While the exact nature or characteristics of the features extracted from the EEG records by the deep learning algorithm are not entirely understood, the features are believed to include hierarchically filtered versions of the data forming the record.
[0033] A similarities algorithm is then applied to the input feature vector and the search feature vectors to identify a subset of search EEG records having a measure of similarity with the input EEG records. The similarities algorithm may be a k-nearest neighbors algorithm that uses the feature vectors extracted by the deep learning algorithm from the input EEG record as a center point, and identifies the closest search feature vector neighbors to the center point based on a distance calculation between the center point and the neighbors. The closest neighbors to this center point are the EEG records in the set of search EEG records that the similarities algorithm identifies as most like the input EEG record. These similar search EEG records are output as search results. The similarities algorithm may be a clustering algorithm, such as a K-means clustering algorithm. Several clustering algorithms are described in Survey of Clustering Algorithm, by Rui Xu and Donald C. Wunsch, IEEE Transactions on Neural Networks, Institute of Electrical and Electronics Engineers, May 2005.
[0034] Once a similar search EEG record is identified, the identity of the patient to whom the search EEG record belongs is known. If information in addition to EEG records exists in the database (or another database) relative to each other patient associated with a search EEG record, then the clinician can call up that information, or the information may be automatically extracted from the database and presented to the clinician. The additional information may comprise, for example, clinical information about the patient's response to a therapy (neurostimulation and/or drug), other aspects of the patient's clinical history, such as past and current neurostimulator parameter settings, and drug therapy information. The clinician may be able to display the similar search EEG records along with this other information in various ways using a user interface connected to the database. In one scenario, the clinician can review the clinical information of the other patients associated with the similar search EEG records and then choose to treat the subject patient with one or more neuromodulation therapies that have been effective for the other patient(s). For example, the clinician may change the value of one or more of the programmable parameters of the subject patient's implanted neurostimulation system to match those used for one of the patients who were identified in the similar search EEG records. Additional information, including the similar search EEG records themselves, may also be extracted from the database and displayed. For example, EEG records in the form of spectrograms may be extracted and displayed
[0035] Having thus provided a general example of a system that identifies relevant clinical information for a patient based on electrical activity of the patient's brain and electrical activity of other patients' brains, a further detailed description of the system follows.
[0036] Overview of System
[0037]
[0038] EEG records are a form of patient data and, in this example, are captured by the implanted neurostimulation system 102. These EEG records may correspond to digitally recorded time series samples of electrocorticographic activity (e.g., a time series waveform). These EEG records may also be in another form or format derived from the time series samples. For example, an EEG record may be a spectrogram image or a time series waveform image of the brain electrical activity. (It will be appreciated that any time-series EEG can be represented as a spectrogram.) Alternatively, time-series waveforms may be directly used.
[0039] The neurostimulation system 102 includes implantable components, namely, an active medical device or neurostimulator, and one or more electrode-bearing leads. The electrodes are configured to rest in or on neural tissue in the patient's brain when the leads are implanted. The neurostimulator may be configured to be implanted in or on the patient's cranium or elsewhere in the patient (e.g., pectorally). Once the neurostimulator is implanted, a proximal end of each lead is connected to the neurostimulator. The combination of the active implanted medical device and the implanted lead(s) is configurable to sense physiological signals from the brain, process and store records of the sensed signals, and deliver a form of stimulation to the brain in response to a predefined trigger, such as the detection by the neurostimulator of a predefined condition or neurological event. In this example, the physiological signals the electrodes sense and transmit through the lead(s) to the neurostimulator are electrocorticographic signals. The form of stimulation delivered through the electrodes to the brain tissue is electrical stimulation. The neurostimulator is configured to record samples or segments the sensed EEGs, and to store them in a memory. Once acquired by the neurostimulator, an EEG record can be relayed elsewhere, such as to an external component like the database 106 either directly or through an interim external component. In this example, the patient monitor 110 can be used with an accessory (not shown) to establish a communications link 112 with the implanted neurostimulator (e.g., a short-range telemetry link), which allows EEG records stored on the neurostimulator to be transmitted to the patient monitor 110. Once on the patient monitor, the EEG records can be transmitted to the database 106 via the network 108 (which may comprise a physical 114, WiFi, or cellular internet transmission).
[0040] Alternatively, the clinician may be provided with an external component, such as a programmer 116 that, like the patient monitor 110, is configured to establish a communications link 118 with the implanted neurostimulator. The programmer can be used by the clinician to adjust the programmable parameters of the neurostimulator (e.g., the parameters that govern the electrical stimulation waveform that is used for therapy). The programmer also may be used to display the real time EEG signals being sensed by the electrodes from the patient and to store them on the programmer. It also can be used like the patient monitor 110 to acquire EEG records that have been stored by the neurostimulator since the last time the neurostimulator was “interrogated” for those EEG records by either a patient monitor 110 or programmer. As is the case with a patient monitor 110, once EEG records are stored on a programmer, they can be transmitted via the network 108 to other components of the system 100, such as the database 106 and/or the records processor 104 (either directly or via the database 106).
[0041] This particular implanted neurostimulation system 102 is configured to deliver electrical stimulation therapy in response to “events” that the neurostimulator is configured to detect. An event may be defined for the neurostimulator by setting the values of programmable detection parameters such that when a pattern corresponding to a pattern defined by the detection parameters occurs in the monitored EEG signals, the occurrence of that pattern will be detected as an event. Other implantable neurostimulation systems that might be used in the subject system may not have this feature of responsive neurostimulation at all or may not have it enabled. The neurostimulator may be programmed to store an EEG record whenever it detects an event (e.g., to store an EEG signal spanning the time period 60 seconds before the event was detected and 30 seconds after). It also can be programmed to store EEG signals at certain times of day (e.g., at noon and at midnight). These are sometimes referred to as “scheduled EEGs.” In addition, then neurostimulator may be configured to store an EEG record upon some other trigger, such as when the patient swipes a magnet over the location on the patient's body at which the neurostimulator is implanted (the patient might be instructed to do this whenever he or she thinks a seizure is coming on).
[0042] Thus, for a given patient, the database 106 may contain EEG records corresponding to what is happening in the patient's brain in real-time (e.g., as acquired by a programmer), EEG records corresponding to what is happening in the patient's brain during and around when an event occurs, scheduled EEG records acquired at a particular time, and EEG records stored by the neurostimulator when a patient triggers storage with a magnet. Some of these EEG records, especially the ones recorded at the time of an event or when triggered by a magnet swipe, may reflect the patient's electrographic seizures. The database 106 may include information about whatever triggered the neurostimulator to store a given EEG, such as the type of event (e.g., Pattern “A” or Pattern “B”, a magnet swipe) or the time of day (e.g., scheduled EEG). The database 106 may accumulate other information acquired from the neurostimulator as well, such as the history of the values used for the programmable parameters of the patient's neurostimulator may be in the database 106 as well, both for detection (if detection is/was enabled) and for stimulation, up to and including the present values for those parameters. Each patient in the database 106 may be associated with an identifier that links each EEG record with a patient or a neurostimulator (e.g., a patient identification number or a medical device serial number). The identifier may be included with each EEG record itself, for example, in a header portion of the digital data sample file that includes the record.
[0043] In addition to information acquired from a patient's implanted neurostimulator and lead(s) (neurostimulator-reported information), the database 106 may contain a lot of other information about the patient from a variety of sources, e.g., other databases (electronic health records), data entered by a clinician, and the results of other algorithms run on data about the patient. For example, the patient's clinical history may be in the database, including that history which relates to the condition or disorder that led the patient to have the neurostimulation system 102 implanted in the first place (e.g., epilepsy). The database 106 may include information about drug therapy(ies) to which the patient has been subjected (during or before or after neuromodulation therapy), such as type of drug, dose, and time of day of dose. The patient's clinical response to a form of therapy may also be in the database 106. For example, if the patient has epilepsy, the database may contain patient-reported seizure information, from which a clinician may infer that a patient is having fewer seizures, more frequent seizures, or no appreciable change in seizures. This data may be imported into the database 106 from other sources, such as a patient's electronic health record or personally maintained paper or electronic “seizure diary.”
[0044] Clinical information about a patient may also be made available to the records processor 104 and/or database 106 by the patient's treating clinician or by the patient herself. For example, during a doctor's visit, the patient may inform the doctor about any changes to health, disease severity which will be updated by the doctor in the patient's clinical information records which is then transmitted to the database. Another example is the doctor may enter information into the records processor 104 that reflects changes to drugs types and dosage prescribed to the patient. The records processor 104 will then transmit the information to the database 106 for storage.
[0045] The database 106 may store other information about a patient as the result of other algorithms or computations. For example, an algorithm within the database 106 may be run on the patient's EEG records to classify the EEG records as evidencing an event or condition, such as those evidencing an electrographic seizure or onset of an electrographic seizure, and those evidencing no electrographic seizure activity at all or those considered to comprise a “baseline” condition for the patient.
[0046] Clinical information may also be periodically transmitted to the database 106 from a programmer 116 during or soon after a patient follow-up, or anytime a clinician makes changes to the neuromodulation therapy of the patient. Ideally, all the information about a particular patient in the database 106 is maintained to be as current and comprehensive as possible, relative to the reason the patient has the implanted neurostimulation system 102. For example, for any patient actively being treated with the neuromodulation therapy delivered by an implanted neurostimulation system 102, the programmer 116 should be used to transmit current neurostimulator-reported information (stored EEGs, settings for programmable parameters, etc.) to the database 106 at or shortly after the time of a patient visit.
[0047] While
[0048] Patient Records and Clinical Information
[0049] An aspect of the disclosed system and method depends on the availability of a large amount of patient records for analysis by a deep learning based algorithm. As noted above, the system 100 may collect and store in the database 106, thousands of patient records received from different implanted neurostimulation systems 102 across a patient population, together with corresponding clinical information for each patient.
[0050] A patient record in the form of an EEG record represents electrical activity of the brain as sensed by the implanted neurostimulation system 102 corresponding to different times or events or triggers. For example, a neurostimulator can be configured to acquire an EEG when an event the neurostimulator is programmed to detect is detected (and the event may be defined by the neurostimulator's detection parameters to correspond to an electrographic seizure or the onset of an electrographic seizure). It can also be programmed to record an EEG when a patient or caregiver swipes a magnet near the implanted neurostimulator, or at certain times of day or according to a particular schedule. EEGs that do not reflect abnormal activity may be designated as baseline EEG records. The neurostimulator is configured to record an EEG signal as a series of digital data samples, and thus an EEG record typically is transmitted to the database 106 in this format to be stored. The time series of data samples can be used to display the EEG record as a waveform. Each such EEG record also can be transformed (by well-known techniques) into a spectrogram and used in that form. The database can be configured to create an EEG record in the desired form, e.g., time-series waveform or spectrogram, whenever the EEG record is called for by an algorithm (e.g., to display it to a clinician and/or use it in a deep learning algorithm). Alternatively, the EEG records can be created in different formats and stored in those formats at the time they are received into the database 106. Systems and methods disclosed herein may operate on different formats of the EEG recording. For example, a deep learning algorithm may process images (the EEG records as spectrograms). In one circumstance, the system 100 may display EEG records to a clinician as time-series waveforms, and prompt the clinician to select one or more of the EEG records for use as inputs to an instance of the deep learning algorithm. Once the doctor selects some EEG records, the system 100 may convert each selected EEG record to an image before processing them with the deep learning algorithm.
[0051] The system and method also depends on the availability of clinical information of patients. As mentioned above, clinical information may include a patient's clinical history, clinical response to neuromodulation therapies, past and current neurostimulation system detection parameter settings and electrical stimulation parameter settings, and past and current drug information. Some or a portion of clinical information may be stored in a neurostimulation system 102 of a patient and periodically transmitted to the database 106. Clinical information may also be transmitted to the database 106 by a clinician through a programmer 116. The record of a patient's clinical information stored in the database 106 includes a patient identifier, which may be in the form of the serial number of the neurostimulation system that provided the clinical information to the database 106 or a patient identification number. As described below, this patient identifier allows for the matching of a patient's clinical information with that patient's records.
[0052] Clinical information may be associated with a patient record. For example, each EEG record received from a neurostimulation system may have an associated triggering event that caused the neurostimulation system to record and store the EEG record. For an implanted neurostimulation system, such triggering events may include: 1) detection of abnormal ECoG activity, 2) time of day, or 3) user initiated storage. Clinical information may also be associated with a patient record after it has been transmitted and stored in the database 106. For example, a classification algorithm module associated with the database 106 may process EEG records to determine a classification for the EEG. These EEG classifications may include, e.g., seizure, seizure onset, or baseline. Other types of information include an identifier that links the EEG record with a patient or a neurostimulation system. For example, an identifier of the neurostimulation system that provided the EEG record to the database 106 may be provided in the form of a system serial number or patient identification number. The identifier may be included with the EEG record, perhaps for example, in a header portion of the digital data sample file that includes the record.
[0053] Records Processor
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[0055] In general, the records processor 104 uses a deep learning based algorithm to recognize similarities between one or more input records and a set of search records. The records of the subject patient and the other patients are of the same format, and may for example, be a spectrogram image of an EEG record. A non-exhaustive list of other possible record formats includes a time-series waveform image of an EEG record or a Fourier or wavelet transformed version of the time-series EEG record. Once similarities between an input record and search records are established, the records processor 104 identifies one or more of the search records as a set of search results and extracts clinical information associated with the identified search records, and acts on the extracted clinical information by either providing the information to a user interface or modifying operation of the subject patient's implanted neurostimulation system.
[0056] In accordance with the method of
[0057] In the case of a single input record, at block 312 of
[0058] Continuing for now with
[0059] After receiving multiple input records, the feature extraction module 204 processes the multiple records. To this end, at block 318 of
[0060] In another embodiment, at block 320 of
[0061] In another embodiment, at block 322 of
[0062] Next, at block 324, the feature extraction module 204 separately applies a similarities algorithm 216 to each set of input feature vectors to identify a separate one of the input-data features vectors for each set of input feature vectors as one of the plurality of input feature vectors 208. As an outcome of this multiple processing, the feature extraction module 204 provides multiple input feature vectors 208 to the similarities module 202.
[0063] An example operation of the similarities algorithm in the context of blocks 322 and 324 is provided by
[0064] Returning to
[0065] In one embodiment, the set of search feature vectors 212 is obtained from the feature extraction module 204. In this case, at block 326 of
[0066] At block 328, the feature extraction module 204 applies the deep learning algorithm to each search record in the set of search records to derive a corresponding search feature vector for each search record. The result of this individual processing of each search record, is a set of search feature vectors 212. After the feature extraction module 204 identifies the input feature vectors, at block 329, the process returns to block 306 of
[0067] In another embodiment, at block 330 of
[0068] Returning to
[0069] In cases where a single input feature vector is obtained, a single subset of search records is identified. An example operation of the similarities module 202 in this context is provided by
[0070] In cases where multiple input feature vectors are obtained, the similarities algorithm is separately applied to each input feature vector, together with the set of search feature vectors, to identify a separate subset of search records for each of the plurality of input records. An example operation of the similarities module 202 in this context is provided by
[0071] Returning to
[0072] In addition to extracting clinical information and search records, the clinical information extraction module 206 may be configured to rank the search results based on measures of similarity of the search records included in the search results 218. To this end, the search results 218 provided to the clinical information extraction module 206 may further include the similarity measures for each search record. Using this information, the clinical information extraction module 206 may rank the search records identified in the search results from most similar to least similar, relative to the subject patient's input record.
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[0074] With reference to
[0075] In the foregoing examples, the search results are described in terms of patients and patient identification numbers. While such description is useful in the sense that it conveys the concept of matching a subject patient with other similar patients for purposes of modifying neuromodulation therapy, from a technical implementation perspective, the system is identifying neurostimulation systems (not patients) that provided search records that appeared in search results. From a practice perspective, a clinician having knowledge of which neurostimulation systems are implanted in which patients would of course be able to match patients with the search results.
[0076] Returning to
[0077] In another implementation, the output 220 includes programming instructions configured to reprogram one or both of the detection parameter settings and the stimulation parameter settings for the patient's implanted neurostimulation system to correspond to the detection parameter settings and the stimulation parameter settings included in the extracted clinical information of one of the search records in the search results. For example, the stimulation settings included in the clinical information associated with the top search result may be selected. In this case, the output 220 may encompass programming instructions that are sent to a programmer 116 over communication link 120. The programmer 116, in turn, may process the programming instructions and autonomously reprogram the settings of the implanted neurostimulation system 102 over communication link 118.
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[0079] A measure of similarity 914 is associated with each identified search record in the search results and the records are sorted in order of similarity, with the first displayed spectrogram record 904 having the highest similarity to the input spectrogram 902. Along with displaying spectrogram images, the measure of similarity between the input image and each search-result image, referred to as a similarity index, is displayed for each search record in the search results. In the example of
[0080] In some instances, a filter may be applied to limit the number of search records included in the search results. For example, the similarity index may be used as a filter. To this end, the number (x) of records in the search results may be limited using a cutoff applied to the similarity index (such as the Euclidean distance). For example, a cutoff value of 15 for the Euclidean distance may be applied so that only those search records in the search results that have a Euclidean distance <15 from the input spectrogram image are displayed. In another example, a filter may be applied to find only the most similar or the best matching image from each search patient to avoid finding several images from the same patient. Application of this filter will ensure that multiple different patients are identified by the records processor 104. If the clinician chooses not to apply this filter, top matched search records will be displayed irrespective of the patient identification. In this case, several search records in the search results may come from the same patient(s).
[0081] Clinical information is associated with each spectrogram record 904, 906, 908, 910, 912 included in the search results. In the example of
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[0083] Having thus described the configuration and operation of a system 100 including a records processor 104 that searches for and identifies relevant clinical information for a patient through deep learning, an overview of an example implanted neurostimulation system that may be included in the system is provided.
[0084] Overview of Implanted Neurostimulation System
[0085]
[0086] The neurostimulator 1102 includes a lead connector 1108 adapted to receive one or more of the brain leads, such as a deep brain or depth lead 1104 and a cortical strip lead 1106. The depth lead is implanted so that a distal end of it is situated within the patient's neural tissue, whereas the cortical strip lead is implanted under the dura mater so that a distal end of it rests on a surface of the brain. The lead connector 1108 acts to physically secure the brain leads 1104, 1106 to the neurostimulator 1102, and facilitates electrical connection to conductors in the brain leads 1104, 1106 coupling one or more electrodes at or near a distal end of the lead to circuitry within the neurostimulator 1102.
[0087] The proximal portion of the deep brain lead 1104 is generally situated on the outer surface of the cranium 1110 (and under the patient's scalp), while the distal portion of the lead enters the cranium 1110 and is coupled to at least one depth electrode 1112 implanted in a desired location in the patient's brain. The proximal portion of the cortical lead 1106 is generally situated on the outer surface of the cranium 1110 (and under the patient's scalp), while the distal portion of the lead enters the cranium 1110. The distal portion of the cortical lead 1106 includes at least one cortical electrode (not visible) implanted in a desired location on the patient's brain.
[0088]
[0089] The neurostimulator 1102 includes a lead connector 1108 adapted to receive a connector end of each brain lead 1104, 1106, to thereby electrically couple each lead and its associated electrodes 1212a-d, 1214a-d with the neurostimulator. The neurostimulator 1102 may configure an electrode 1212a-d, 1214a-d as either a sensor (for purposes of sensing electrical activity of the brain) or a stimulator (for purposes of delivering therapy to the patient in the form of electrical stimulation) or both.
[0090] The electrodes 1212a-d, 1214a-d are connected to an electrode interface 1220. The electrode interface 1220 can select each electrode 1212a-d, 1214a-d as required for sensing and stimulation. The electrode interface 1220 may also provide any other features, capabilities, or aspects, including but not limited to amplification, isolation, and charge-balancing functions, that are required for a proper interface with neurological tissue. The electrode interface 1220 is coupled to a detection subsystem 1226, which is configured to process electrical activity of the brain sensed through the electrode 1212a-d, 1214a-d. The electrode interface 1220 may also be coupled to a therapy subsystem 1228, which is configured to deliver therapy to the patient through the electrode 1212a-d, 1214a-d in the form of electrical stimulation.
[0091] The neurostimulator 1102 includes a memory subsystem 1238 and a central processing unit (CPU) 1240, which can take the form of a microcontroller. The memory subsystem 1238 is coupled to the detection subsystem 1226, and may receive and store records of data representative of sensed electrographic signals for transmission to the system of
[0092] The neurostimulator 1102 also includes a communication subsystem 1242. The communication subsystem 1242 enables communication between the neurostimulator 1102 and an external device, such as a programmer 116 or patient monitor 110, through a wireless communication link. As described above with reference to
[0093] Overview of Computing Device with Records Processor
[0094]
[0095] The computing device 1300 includes a central processing unit (CPU) 1302 that implements the various modules of the records processor 104 described above with reference to
[0096] Computer readable media 1304 suitable for storing records processing instructions include all forms of non-volatile memory, media, and memory devices, including by way of example semiconductor memory devices, flash memory devices, magnetic disks, magneto optical disks and CD ROM and DVD-ROM disks. In operation, the CPU 1302 executes the records processing instructions stored in the computer readable media 1304 to thereby perform the functions of the similarities module 202, the feature extraction module 204 and the clinical information extraction module 206 of the records processor 104 according to the methods of
[0097] The user interface 1308, which may be a keyboard or a mouse, and the display 1310 allow for a clinician to interface with the computing device 1300 and the components of the system 100, including the database 106. For example, a clinician seeking to improve the therapy outcome of a subject patient using the system may access the database 106 through a graphical user interface (GUI) on the display 1310 and select an input record or a number of input records of a subject patient for processing. The clinician may then initiate execution of the records processing instructions stored in the computer readable media through the GUI, and await a display of the search results and relevant clinical information. The input record and search result records may be displayed as shown in
[0098] Once the search results are obtained, the clinician may further interact with the system 100 through the user interface 1308 to access additional relevant clinical information stored in the database 106 associated with the search results (and the search patient associated with the search results). For example, the search patient's clinical response to a therapy (e.g., electrical stimulation) or combination of therapies (e.g., electrical stimulation and drug therapy), medical history, history of settings for an active implantable medical device (such as the values of the parameters in a neurostimulator), history of a pharmaceutical (drug) therapy (e.g., type of drug(s), dose of drug, time of delivery of dose), the outcomes or other measure of effectiveness of a given course of treatment or therapy for the search patient, and the results of an analysis of data pertaining to the search patient, such as an algorithm that classifies the search patient's EEG records into one or more types, may be accessed. The clinician may use this additional clinical information to inform her decisions regarding the neuromodulation therapies of the subject patient.
[0099] The various aspects of this disclosure are provided to enable one of ordinary skill in the art to practice the present invention. Various modifications to exemplary embodiments presented throughout this disclosure will be readily apparent to those skilled in the art, and the concepts disclosed herein may be extended to other magnetic storage devices. Thus, the claims are not intended to be limited to the various aspects of this disclosure, but are to be accorded the full scope consistent with the language of the claims. All structural and functional equivalents to the various components of the exemplary embodiments described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. § 112, sixth paragraph, unless the element is expressly recited using the phrase “means for” or, in the case of a method claim, the element is recited using the phrase “step for.”